Advancing Diabetes Care: Highlights from the ADA’s 84th Scientific Sessions

The American Diabetes Association (ADA), a premier voluntary health organization, has been at the forefront of combating the diabetes epidemic and enhancing the lives of individuals with diabetes for 83 years. The ADA has consistently fueled discovery and research aimed at treating, managing, and preventing diabetes, with an unwavering commitment to finding a cure. Its efforts extend beyond research to include advocacy, program development, and education, all aimed at improving the quality of life for over 136 million Americans living with diabetes or prediabetes.

The ADA’s 84th Scientific Sessions, the largest global scientific meeting dedicated to diabetes research, prevention, and care, recently took place in Orlando, FL, from June 21-24. The event attracted over 11,000 leading physicians, scientists, and healthcare professionals from around the world, both in person and virtually. This gathering served as a platform for the presentation of groundbreaking research, new treatment guidelines, and advancements toward a diabetes cure. Attendees had the exclusive opportunity to engage with thousands of original research presentations and participate in stimulating discussions with renowned diabetes experts, contributing to the ongoing effort to improve diabetes care and outcomes.

Here are five highlights from the ADA’s 84th Scientific Sessions:

1. Transforming OSA and Obesity Care: Dual Benefits of Lilly’s Tirzepatide

Obstructive Sleep Apnea (OSA) affects over 1 billion people globally and is highly prevalent among individuals with obesity, with approximately 40% of obese individuals suffering from OSA. This condition disrupts sleep due to repeated airway obstruction, contributing to serious health issues such as hypertension, cardiovascular disease, and impaired cognitive function. Traditional treatments like continuous positive airway pressure (CPAP) focus on airway patency but do not address obesity, highlighting the need for comprehensive solutions.

The SURMOUNT-OSA study investigates tirzepatide, a novel therapy targeting both OSA and obesity. In pivotal trials involving 469 participants, tirzepatide significantly reduced the apnea-hypopnea index (AHI) by -27.4 to -30.4 events per hour in those unable or unwilling to use CPAP (Study 1) and similarly in patients already using CPAP (Study 2). Participants also experienced substantial weight loss (18-20%) and improvements in cardiovascular risk factors like systolic blood pressure. These findings suggest tirzepatide could revolutionize treatment for OSA and obesity, potentially improving sleep quality and overall health outcomes.

Tirzepatide emerges from these trials as a promising dual therapy for OSA and obesity, offering significant reductions in sleep-disordered breathing and cardiovascular risks. Further research could establish it as a transformative option for millions affected by these interconnected health challenges.

Tirzepatide enters a competitive market with a price slightly below semaglutide, expecting co-existence and market growth acceleration despite semaglutide’s edge in comorbidity benefits.

As per DelveInsight’s analysis, tirzepatide is anticipated to grow at an exponential rate and is likely to capture ~35% of the obesity market by 2034.

2. Mannkind Corporation Announced Positive Results From INHALE-3 Trial

The INHALE-3 trial evaluated the effectiveness of inhaled insulin AFREZZA combined with degludec insulin TRESIBA compared to standard care in 123 adults with Type 1 diabetes across 19 US centers over 17 weeks. Participants continued their usual insulin regimen, either including automated systems or injections, or switched to the inhaled insulin regimen. The primary endpoint was the change in HbA1c levels, with secondary measures focusing on time-in-range and hypoglycemia rates using continuous glucose monitoring.

Results showed significant improvements with inhaled insulin: 21% achieved an HbA1c reduction exceeding 0.5%, compared to 5% in standard care. Notably, 21% of those with baseline HbA1c ≥7% reached the <7% target with inhaled insulin, versus none in standard care. However, 26% of inhaled insulin users saw HbA1c worsen by >0.5%, contrasting with 3% in standard care. Despite the variability, over half of the participants expressed interest in continuing inhaled insulin, highlighting its potential as an appealing option for managing Type 1 diabetes.

The INHALE-3 trial underscores inhaled insulin’s promise in improving glycemic control and addressing the diverse needs of Type 1 diabetes patients, despite observed variability in individual responses. This alternative delivery method offers significant HbA1c benefits and may enhance patient satisfaction compared to traditional insulin therapies.

However, inhaled insulin often comes with a higher price tag compared to injectable insulin, which may pose a financial challenge for some patients. Insurance coverage can differ, so it is crucial to verify with your provider whether inhaled insulin is included in your plan.

Fortunately, many manufacturers offer affordability programs that can help reduce the costs for eligible individuals.

3. Semaglutide’s Impact on Glycemic Control in Cardiovascular and Overweight Populations: Insights and Implications

The SELECT trial evaluated the impact of semaglutide on glycemic control in individuals with cardiovascular disease, overweight, or obesity but without diabetes. Over 17,000 participants were studied, with half receiving semaglutide and the others a placebo over an average follow-up of nearly 3.5 years. Results showed that semaglutide led to a significant initial decrease in HbA1c levels compared to placebo, with this difference maintained throughout the study period. Additionally, participants on semaglutide experienced a substantial reduction in body weight, stabilizing after about 65 weeks and resulting in a notable increase in the proportion achieving normoglycemia and a decrease in those progressing to biochemical diabetes by week 156. The study concluded that while semaglutide effectively promotes regression to normoglycemia and reduces the onset of diabetes, it does not alter the natural progression of glycemia over time in this population.

This research underscores semaglutide’s potential in managing glycemic outcomes in individuals with cardiovascular risk factors and overweight or obesity, highlighting its role in early intervention strategies to prevent diabetes onset. The findings suggest that the medication’s benefits extend beyond weight management, impacting metabolic health by improving glycemic control profiles significantly. However, the study also indicates that while semaglutide effectively modifies immediate glycemic parameters, it does not impede the overall progression of glycemia over the long term. These insights contribute valuable evidence for clinical decision-making in addressing metabolic health in at-risk populations without diabetes.

SELECT’s positive cardiovascular outcomes establish a crucial link between weight management and life-saving impacts, potentially catalyzing rapid expansion in the obesity market and offering significant cost-offsets for healthcare systems.

As per the analysis, Novo Nordisk’s semaglutide secured nearly 95% of the USD 4.7 billion total market in 2023 due to superior weight loss efficacy.

4. Semaglutide in T2D and CKD: Transformative Results from the FLOW Trial

The FLOW trial investigated the efficacy of once-weekly semaglutide in patients with Type 2 diabetes (T2D) and chronic kidney disease (CKD). This Phase IIIb trial enrolled over 30,000 participants across 28 countries, demonstrating a 24% lower risk of major kidney outcomes with semaglutide compared to placebo, including kidney failure and a significant decline in estimated glomerular filtration rate (eGFR). Additionally, semaglutide showed significant reductions in cardiovascular events, with an 18% lower risk of composite cardiovascular outcomes and a 20% reduction in all-cause mortality over a median follow-up of 3.4 years. The trial also highlighted the potential benefits of combining semaglutide with sodium-glucose cotransporter-2 (SGLT2) inhibitors for managing T2D and CKD, though further studies are needed to confirm these findings.

The study population, predominantly older with high cardiovascular risk and long-standing diabetes, benefited from semaglutide’s effects on both kidney and cardiovascular health. The findings underscore the importance of GLP-1 receptor agonists like semaglutide in managing T2D complications, particularly in patients at risk for progressive kidney disease and cardiovascular events. Moving forward, integrating semaglutide with SGLT2 inhibitors may offer synergistic benefits for comprehensive diabetic care, pending additional research to elucidate optimal treatment strategies.

In conclusion, the FLOW trial supports semaglutide as a promising therapeutic option for patients with T2D and CKD, showing robust efficacy in reducing major kidney and cardiovascular events. The results emphasize the potential of GLP-1 receptor agonists in enhancing outcomes in this high-risk population, suggesting avenues for future treatment optimization and combination therapies to further improve patient outcomes.

The success of semaglutide in reducing CVD events by 20% in a major international study in clinical trials suggests that the drug may be on a bigger, broader, and more lucrative path.

5. RELIEF-DPN 1: Lexicon Pharmaceuticals’s Drug Addressing Challenges in Diabetic Peripheral Neuropathic Pain Management

In the RELIEF-DPN 1 Phase II study, LX9211, an inhibitor of AP2-associated protein kinase 1 (AAK1), was evaluated for its effectiveness in managing diabetic peripheral neuropathic pain (DPNP) in patients with Type 1 or 2 diabetes. Through structured patient interviews across 31 clinical sites in the US, the study aimed to characterize the disease burden and assess unmet needs in DPNP management. Findings revealed that numbness, tingling, and burning sensations were the most commonly reported symptoms, with burning being the most bothersome to a significant portion of patients. The impact on daily life was profound, particularly affecting sleep, mood, and mobility. Importantly, a substantial proportion of patients expressed dissatisfaction with current treatment options, underscoring the urgent necessity for improved therapeutic approaches in DPNP management.

This sub-study underscores the substantial impact of DPNP on patients’ quality of life and the challenges they face in managing this condition effectively. The high prevalence of symptoms like numbness and tingling, coupled with their significant impact on sleep and mood, highlights the critical need for innovative therapies that can address these burdensome symptoms more effectively. Efforts to develop treatments that alleviate DPNP symptoms and improve overall patient satisfaction remain paramount in advancing care for individuals with diabetic peripheral neuropathy.

As per the analysis, LX9211, expected to launch in 2028, is anticipated to become a blockbuster therapy in the PNP market by 2032, generating significant revenue in the United States.